Morning Plenary Session
Welcome and Introduction of Dr. Julie Gerberding
Marshalyn Yeargin-Allsopp, M.D., Medical Epidemiologist, National Center on Birth Defects and Development Disabilities, CDC, DHHS
On behalf of the Interagency Coordinating Committee, Dr. Yeargin-Allsopp opened the plenary session and welcomed the participants to the fourth Study Assembly Meeting of the National Children’s Study. Dr. Yeargin-Allsopp described the meeting’s theme as community engagement and partnerships, with the primary meeting objectives as follows:
- Discuss and obtain feedback on the plans for Study implementation
- Identify key steps for community involvement and participant recruitment, including how stakeholders from regional, state, and local arenas can be involved
- Share information about the Study’s priorities, themes, and outcomes
- Report on the status of methods development studies over the past year
- Report on the status, needs, strategies, and funding of the Study.
The Public’s Health and the National Children’s Study
Julie L. Gerberding, M.D., M.P.H., Director, CDC, DHHS
Dr. Gerberding described the purpose of her presentation as putting children’s health and the Study into the greater context of public health issues. Dr. Gerberding noted that urgent or acute problems are not "the whole story" and that there is a vital need to pay attention to health promotion, health protection, and health improvement for people in all stages of life, especially children. She noted that for children from 1 to 4 years of age, the leading causes of death are:
- Unintentional injuries
- Birth defects
- Cancer
- Homicide
- Heart disease
- Infectious diseases, particularly pneumonia and influenza.
The more the scientific community understands about the genesis of these problems-particularly the environmental, behavioral, and genetic contributions-the more able they will be to identify interventions that will be successful in reducing these problems.
Dr. Gerberding emphasized the importance of following children prospectively as they emerge into adulthood to be able to understand the determinants of illness, disease, and disability that may have their genesis in childhood. Many of the causes of death in adults are preventable, and many of the contributing factors to death have their roots in childhood and early health behaviors. The stage is set very early in life to determine the health behaviors and the health outcomes of adults. The behavioral risk factors are often apparent. As examples, Dr. Gerberding cited tobacco use and physical inactivity/lack of exercise.
The real value of the Study, Dr. Gerberding noted, is to comprehensively examine the environmental and behavioral determinants of health status. Because most environmental and behavioral determinants are modifiable, interventions can be designed to improve health outcomes. In conclusion, Dr. Gerberding characterized the Study as a giant step forward, leading to a healthier future for all of America’s children.
Introduction of Dr. Duane Alexander
Peter C. Scheidt, M.D., M.P.H., Director, National Children’s Study Program Office, NICHD, NIH, DHHS
Dr. Scheidt described the career of Duane Alexander, M.D., Director, NICHD, NIH, DHHS. Dr. Alexander, who has ultimate responsibility for the Study, has been a passionate supporter and leader in the Study’s commitment to America’s children.
The National Children’s Study: The Key to Children’s Health
Duane Alexander, M.D., Director, NICHD, NIH, DHHS
The purpose of Dr. Alexander’s presentation was to review the history and status of the National Children’s Study. He described the following:
- The background of how the Study came into existence
- What the Study is trying to accomplish
- The status of the planning process for the Study
- How the community can provide input and help in the process of implementing the Study.
The National Children’s Study had its genesis with the President’s Task Force on Environmental Health Risks and Safety Risks to Children, which recommended a prospective, longitudinal, national birth cohort study of a long duration and significant size to assess the influences on children’s health and development. The Study became a reality with the passage of the Children’s Health Act of 2000 and the authorization of funding to begin planning the Study. Dr. Alexander emphasized that the Study is "hypothesis driven" and that data will be gathered to answer specific questions. However, the actual breadth and depth of the Study can best be appreciated by attending to the broad areas of outcomes and exposures for which measures are currently being developed.
Five areas of priority health and disease outcomes have been identified:
- Pregnancy outcomes
- Neurodevelopment and behavior
- Childhood injury
- Asthma
- Obesity and physical development.
The evaluations and measurements of exposure will include the following:
- Physical environment
- Chemical exposures
- Biological environment
- Psychosocial environment
- Genetics.
Specific criteria for the core hypotheses have been developed. Other hypotheses may be developed, providing that:
- They are important for issues of children’s health and development
- They address a condition having a significantly high prevalence
- The severity of the condition addressed is noteworthy
- They address conditions having a high morbidity or mortality associated with them
- The conditions addressed are contributors of significant disability or health care costs, as well as having a public health significance
- There is a reasonable scientific rationale for the hypothesis
- A sample size of the magnitude of the Study is required
- The hypotheses are measurable and require a longitudinal follow-up.
Dr. Alexander explained that the Study is currently in the process of pilot and methods development studies. Some have been completed; most are still ongoing and a few are in the planning phase. Development of the protocol is beginning. Dr. Alexander noted that the funding to date has been provided by the four participating agencies and has been sufficient only for planning purposes. As yet, there are no appropriations specific to the implementation of the Study. The agencies involved with Study have used funds from their operational budgets for the various pilot and methods development studies. Dr. Alexander reviewed the pilot and methods development studies (the details of which were presented in the afternoon poster session). He noted that 14 workshops or conferences have been held on topics such as assessing innovative technologies for the remote collection of data and ethical issues of longitudinal studies. Recruitment and retention of Study subjects are of particular interest. Consent is a particularly important issue. Dr. Alexander briefly discussed the design of the Study’s consent process.
In terms of the Study’s timeline, Dr. Alexander listed the following tentative milestones:
- Develop final design of the Study by mid 2004
- Begin subject recruitment in late 2005
- Determine initial Study sites by early 2006
- Identify first subjects to be enrolled by early 2006
- Expand full Study from 2005 to 2007
- Collect first birth defects data before 2010
- Complete the 21-year follow-up in 2030.
At this time, it is estimated that the actual Study will require approximately $2.7 billion over a 25-year period. Dr. Alexander commented that the Study is considered a long-term investment because of its implications for future health care. More and more of the burden of health care costs falls on the government. Successfully developing more effective schemes for prevention and intervention will help contain spiraling health care costs. The National Children’s Study is essential if America is to improve the health of its children, improve the capabilities of its children as they become adults, and reduce the burden of disease over the long term. Dr. Alexander concluded by thanking all those involved in the Study for their interest, their past support, and their continuing support in the future.
Introduction of Diane Dennis-Flagler
Sarah A. Keim, M.A., Coordinator, National Children’s Study Program Office, NICHD, NIH, DHHS
Community Partnerships
Diane Dennis-Flagler, M.P.H., Health Scientist, Agency for Toxic Substances and Disease Registry, CDC, DHHS
Ms. Dennis-Flagler commented on the diversity of represented organizations and noted that building relationships and collaborative partnerships would be essential to making the Study a success. One of the expectations of the Study Assembly Meeting is to begin developing collaborative partnerships among Study planners and the community. Ms. Dennis-Flagler said that community input could offer valuable insight and listed the following benefits of community involvement:
- Community input is valuable because it is an effective way of getting the results desired by the Study.
- The community is the best source of information as to what is occurring in the community and the kinds of things the Study should focus on besides the core aspects.
- Community collaboration can provide new insights into Study research topics.
- Community involvement provides the opportunity for the exchange of information.
- Community involvement develops a sense of ownership and commitment to the Study.
Ms. Dennis-Flagler listed some of the challenges of involving communities in the Study, including:
- Certain communities-particularly some minority communities-may have historically suffered from health disparities and may view research and scientists with skepticism; this history will have to be overcome in the Study.
- The Study will have to manage its sheer magnitude and diversity of issues, including disparate geographical locations and numerous cultural and ethnic groups.
Ms. Dennis-Flagler reviewed the chronology of early community involvement efforts by the Study and, in conclusion, noted that questions remain unanswered, particularly:
- What are the expectations of the communities involved in longitudinal studies like the National Children’s Study?
- What are some actual strategies that could be incorporated into the Study to make it more successful?
Introduction of Elise Miller
Sheila Newton, Ph.D., Director, Office of Policy, Planning, and Evaluation, NIEHS, NIH, DHHS
The National Children’s Study: A Bright Star for the Advocacy Community
Elise Miller, M.Ed., Executive Director of the Institute for Children’s Environmental Health
Ms. Miller said that her charge was to represent how the advocacy community perceives the National Children’s Study. The Study is an extraordinary opportunity to ensure that all American children reach their fullest potential. The purpose of Ms. Miller’s presentation was to emphasize how the Study can fulfill its own potential and become the "bright star" that will benefit all of America, including researchers, advocates, health professionals, parents, teachers, and, of course, children.
Ms. Miller described some statistics on health outcomes and noted that many in the public health arena strongly suspect that some pediatric diseases are caused, in part, by exposures to environmental toxins and other preventable risk factors. As examples, Ms. Miller cited:
- The incidence of childhood asthma
- Birth defects
- Childhood leukemia and brain cancer
- Learning, development, or behavioral disorders
- Mental retardation
- Autism spectrum disorders.
Ms. Miller noted that too many children in the United States are suffering from adverse health outcomes for which there are clear costs to society:
- Higher rates of illiteracy
- Higher dropout rates
- Higher rates of crime, violence, and abuse
- Higher unemployment rates
- Higher health care costs.
She noted that there is no dollar measure of the full practical and emotional burden borne by these families, their children, and their communities.
According to Ms. Miller, many chemicals are commercially available and in common use, for which toxicity data are not available and for which there has not been testing of synergistic effects to see how these myriad chemicals affect health outcomes, particularly those for children.
In the United States, cohort studies have been the cornerstone of public health policy. Ms. Miller cited the Framingham study of heart disease and described it as a pivotal event in America’s capacity to address heart disease. The National Children’s Study has the potential to be a similar pivotal event in U.S. public health but for current and future generations. Ms. Miller noted that children comprise 30 percent of the U.S. population, yet only 3 percent of the total collective research budget is dedicated to childhood diseases and disorders. Of that 3 percent, only a small proportion is earmarked for epidemiological research.
Ms. Miller stated that the National Children’s Study is particularly important to the advocacy community because of its promise of translating the best science into better public education and improved public health policies. Epidemiological data generated by the Study will allow the scientific and public health communities to better serve their constituencies and to leverage public health policies that will better protect America’s children. The Study, she said, provides an extraordinary opportunity to "go way upstream" to examine systemic prevention and make comprehensive changes that will result in a brighter future for all of America’s children.
Ms. Miller listed several collaborative initiatives that would benefit from the Study:
- The Environment Health Alliance’s "Be Safe" campaign, which was launched by the Center for Health, Environment, and Justice (www.chej.org) in October 2003.
- The Collaborative on Health and the Environment (www.cheforhealth.org), which was launched in 2002 and consists of more than 700 health professionals, researchers, advocacy organizations, and "health-affected" groups. This initiative is attempting to galvanize the learning and developmental disabilities sector to reduce environmental exposures to toxins that impair neurological development.
- Coming Clean (www.come-clean.org), which is a network of groups and individuals with the common goal of protecting public health and the environment from exposures to harmful and unstudied chemicals.
- The Partnership for Children’s Health and the Environment (www.partnersforchildren.org), which was launched in 1999 by the Institute for Children’s Environmental Health. This initiative brought together representatives from government, academia, and advocacy organizations to draft guiding principles for children’s environmental health.
Ms. Miller summarized some key points that the advocacy community suggests to those involved with the National Children’s Study:
- Keep focused on environmental contributors to children’s diseases and disorders.
- Ensure that community input and engagement are included throughout the Study process.
- Involve experts from across the United States, from universities and local and state health departments to community organizations and representatives.
- Secure and sustain adequate long-term funding and support from the public and the federal government.
Ms. Miller reemphasized that the National Children’s Study will be a bright star for not only the advocacy community but also all of those people who care about children achieving their full potential now and for generations to come. She concluded by quoting Margaret Mead: "Never doubt that a small group of thoughtful, committed citizens can change the world."
Introduction of Dr. Richard Carmona
Woodie Kessel, M.D., M.P.H., Assistant United States Surgeon General, DHHS
Children’s Health in the United States in the 21st Century
Vice Admiral Richard Carmona, M.D., M.P.H., F.A.C.S., United States Surgeon General, Commander, U.S. Public Health Service Commissioned Corps, DHHS
Dr. Carmona described the Study as a legacy that Americans will leave their children and their children’s children. As Surgeon General, Dr. Carmona is responsible for ensuring that all American children are as healthy as possible, both physically and mentally. President George W. Bush, DHHS Secretary Tommy Thompson, and Dr. Carmona all share a passion about the health, the safety, and the welfare of America’s children. To this end, the federal government is meeting many child health challenges, which include:
- Childhood immunizations
- Infant mortality
- Tobacco use
- Teen pregnancies
- Access to health care.
Dr. Carmona reported that:
- The rate of childhood immunization is at an all-time high because of an expansion of the vaccines for children programs to help families that are underinsured.
- Infant mortality is at an all-time low.
- American children are less likely to smoke and less likely to give birth as teenagers.
- Disadvantaged children have better access to health care than before through community health centers and the State Children’s Health Insurance Program.
Through the President’s Task Force on Environmental Health Risks and Safety Risks to Children, the federal government is continuing to find new and better ways to improve children’s health.
Dr. Carmona described the National Children’s Study as "big science for big rewards." Through the results of past scientific research, the political will was developed to enact appropriate safety regulations and laws, as a result of which there have been dramatic improvements in the mortality and morbidity associated with many types of problems.
Today, the public health community is struggling again with chronic disease and its increase among American children. Dr. Carmona explained that an unprecedented number of children are overweight, significantly increasing children’s risk factors for diabetes, heart disease, asthma, and emotional and mental health problems. Through research such as the National Children’s Study, the scientific and public health communities will learn the ways complex factors interact, for the purpose of developing effective ways to curb excess weight and obesity in children. The National Children’s Study will help the scientific and public health communities better understand the link between the environments in which children are raised and their physical and emotional health and development.
The implications of the Study, Dr. Carmona said, are profound. The Study has the potential to reduce the risks of chronic diseases and to improve physical, mental, and emotional health. He emphasized that all Americans will benefit from the National Children’s Study. Just as today’s generation has benefited from the great scientific minds of the past, who made it their life’s work to prevent suffering and misery, the present generation must work for the generations that follow. This Study, he said, will shape the future of medicine and, with it, will shape the future of American’s children.
In concluding, Dr. Carmona urged all of those involved with the Study to:
- Keep thinking imaginatively and critically
- Keep educating, innovating, and collaborating
- Keep asking the right questions
- Be bold, embrace the unknown, and decipher life’s mysteries
- Send America’s children healthy and happy into a future that their parents will not see themselves.
Morning Wrap-Up and Overview of Afternoon Sessions
Pauline Mendola, Ph.D., Epidemiologist, National Health and Environmental Effects Research Laboratory, EPA
Breakout Sessions
Please see Appendixes A-J for breakout session summaries.
Afternoon Plenary Session
Introduction of Grazell Howard
James J. Quackenboss, M.S., Environmental Scientist, National Exposure Research Laboratory, EPA
The National Children’s Study: The Community Perspective
Grazell Howard, Esquire, National Coalition of 100 Black Women, Inc., and CEO of The Libra Group
Ms. Howard described the National Children’s Study as "America’s legacy." She noted that the Study is America’s future and now is the time to begin a creating a campaign, which she compared to a party. In her analogy, Ms. Howard said that timing of the invitations was important: "You don’t want people to show up to the party too early, nor do you want to invite someone too late." A delicate balance needs to be found in forging relationships with those who will make the Study successful, particularly nongovernmental groups such as community and civic organizations. Ms. Howard made the following recommendations and observations for the Study:
- Be fluent in outreach.
- Facilitate prevention, empowerment, and engagement in health care in America.
- Translate scientific data into something the average American can embrace.
- Communicate Study information immediately.
- Share with communities the reasons why the Study makes sense.
- Energize, galvanize, and create noise.
According to Ms. Howard, the human condition is predisposed to helping. Humans like to help other humans, and there are people in every community who will reach out to help others in their community. By acknowledging this openly during recruitment, the Study can form coalitions with existing community relationships and can promote empowerment. She said that the scientific and public health communities and all of those involved with the National Children’s Study must have the courage to change and do things that they typically would not do. To create a "buzz" about the Study, Ms. Howard recommended that those involved with the Study start their campaign at the highest levels of organizations and governments and then work their way down to diverse populations and citizen organizations. The guiding principles for this campaign should be:
- Communication
- Equity
- Representation
- Education
- Outreach.
Ms. Howard emphasized that the scientific activities of the Study and community efforts to embrace the Study must be moving on parallel tracks; there must be a dual campaign. There must be accountability in the Study for sharing with people and communities what lies ahead and what may come from the Study. Ms. Howard stressed the importance of explaining the expectations of the Study, as well as the benefits and commitments. Finally, Ms. Howard recommended that community and citizen organizations be invited early. The successes of the Study must be shared with all who are involved.
Meeting Wrap-Up
Woodie Kessel, M.D., M.P.H., Assistant United States Surgeon General, DHHS
In the final presentation of the open plenary session, Dr. Kessel said that the most important aspect of the Study is to remember the children. Children are the "who" and the "why" of the Study. The fundamental theme of the Study is "community-based and family-centered." According to Dr. Kessel, the "why" of the Study is the real question and the real reason for the Study. The answer to "why" is to improve the health of children. In today’s public health paradigm, scientific research is the driving force in improving health outcomes. Science allows for informed decision making. Science informs the legislative process, which in turn sets public health policy. When public health policies are successfully implemented, then behaviors will change and differences will be made in health outcomes. In concluding, Dr. Kessel reminded participants to "think of the children first because they are the future."